UMIN-CTR Clinical Trial

Public title

Efficacy Study of COmbination of Edoxaban and Physiotherapy on PRevention and Thrombogenicity of Venous-Thromboembolism in patients after Total Knee Arthroplasty

Acronym

Efficacy Study of COmbination of Edoxaban and Physiotherapy on PRevention and Thrombogenicity of Venous-Thromboembolism in patients after Total Knee Arthroplasty(ESCORT-TKA Study)

Scientific Title

Efficacy Study of COmbination of Edoxaban and Physiotherapy on PRevention and Thrombogenicity of Venous-Thromboembolism in patients after Total Knee Arthroplasty

Scientific Title:Acronym

Efficacy Study of COmbination of Edoxaban and Physiotherapy on PRevention and Thrombogenicity of Venous-Thromboembolism in patients after Total Knee Arthroplasty(ESCORT-TKA Study)

Region

Japan

Condition

knee arthrosis

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Deep vein thrombosis often occur fatal pulmonary thromboembolism. Edoxaban is an activated factor ten inhibitor, which has proven the prevention of thromboembolic events in venous thromboembolism(VTE). Recently, the Total Thrombus-formation Analysis System(T-TAS), a microchip-based flow chamber system capable of evaluating thrombogenicity was developed. In this study, we will examine in the incidence of VTE after knee surgery and evaluate how thrombosis forms by utilizing T-TAS.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Differences in incidence rate of venous thromboembolism 7 days after opetration,and the changes in T-TAS parameters between edoxaban plus physiotherapy group and physiotherapy only group.

Key secondary outcomes

Between edoxaban plus physiotherapy group and physiotherapy only group,differences in incidence rate of perioperative bleeding event and the changes in PT and aPTT
function.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

edoxaban plus physiotherapy group

Oral administration of 30 mg of edoxaban once daily will be initiated from the second day after the TKA.

Interventions/Control_2

physiotherapy only group

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

16

years-old

<=

Age-upper limit

85

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Meet the diagnostic criteria for TKA
2)Aged from 16 to 85 years old
3)Willingness to give written informed consent and willingness to participate in and comply with the study

Key exclusion criteria

1)Emergent operation
2)Serious infection
3)Allergy to study drug
4)Current thrombosis
5)Taking anti-thrombotic agents such as, aspirin, P2Y12 inhibitor, warfarin and non-vitamin K oral anticoagulants (NOACs), etc.
6)Unwilling to give informed consent
7)inappropriate patient

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Kenichi Tsujita

Organization

Faculty of Life Sciences, Kumamoto University

Division name

Department of Cardiovascular Medicine

Zip code

Address

1-1-1, Honjo, Chuo-ku, Kumamoto, 860-8556, Japan.

TEL

+81-96-373-5175

Email

tsujita@kumamoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Daisuke Sueta

Organization

Kumamoto University Hospital

Division name

Department of Cardiovascular Medicine

Zip code

Address

1-1-1, Honjo, Chuo-ku, Kumamoto, 860-8556, Japan.

TEL

+81-96-373-5175

Homepage URL

Email

sueta-d@kumamoto-u.ac.jp

Institute

Kumamoto University Hospital, Department of Cardiovascular Medicine

Institute

Department

Personal name

Organization

This study was supported in part by Grants-in-Aid for Scientific Research (#15K09089) from the Ministry of Education, Culture, Sports, Science and Technology of Japan.

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Janan

Co-sponsor

Kumamoto University Hospital, Department of Orthopedic Surgery

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

熊本大学医学部附属病院(熊本県) (Kumamoto University Hospital,Kumamoto Pref.)

Date of disclosure of the study information

2016

Year

01

Month

20

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2016

Year

01

Month

01

Day

Date of IRB

Anticipated trial start date

2016

Year

02

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

01

Month

19

Day

Last modified on

2018

Year

02

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023770